Parasafe(R) Fixative
FDA 510(k) K935316 · Scientific Device Laboratory, Inc.
510(k) numberK935316
Submission
- Device name
- Parasafe(R) Fixative
- Applicant
- Scientific Device Laboratory, Inc.
Glenview, IL, US - Received
- November 2, 1993
- Decision date
- February 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKS – Device, Parasite Concentration
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
Other 510(k)s with product code LKS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053257 | Para-Pro FC50LKS · Traditional | Alpha-Tec Systems, Inc. | 05/12/2006SE |
| K021420 | Paracon Ii/Fecal Concentrator IILKS · Traditional | Para Scientific Co. | 06/04/2002SE |
| K980077 | Para-Pak SpinconLKS · Traditional | Meridian Diagnostics, Inc. | 04/02/1998SE |
| K941110 | ParakitLKS · Traditional | Hardy Diagnostics | 05/17/1994SE |
| K941129 | Con-KitLKS · Traditional | Medical Chemical Corp. | 05/09/1994SE |
| K933370 | Stool Transport/ProcessorLKS · Traditional | Sage Products, Inc. | 02/17/1994SE |
| K931849 | ParaprepLKS · Traditional | Medastat Scientific Corp. | 12/02/1993SE |
| K881649 | Modified Paracon(Tm) Concentration KitLKS · Traditional | Para Scientific Co. | 04/21/1988SE |
| K860034 | Para-Pak Macro-ConLKS · Traditional | Meridian Diagnostics, Inc. | 02/21/1986SE |
| K853715 | Para Con TMLKS · Traditional | Para Scientific Co. | 10/02/1985SE |
More from Para Scientific Co.
| 510(k) | Device | Decision |
|---|---|---|
| K924893 | Microsporidium Control SlideLJG · Traditional | 01/15/1993SE |
| K911059 | Turbidometric StandardLIE · Traditional | 06/10/1991SE |
| K895848 | Pressure Steam SterilizersFLE · Traditional | 12/11/1989SE |
| K890718 | Gram Stain Control SlideLJG · Traditional | 03/16/1989SE |
| K890670 | Cryptosporidium Control SlideLJG · Traditional | 03/16/1989SE |
| K884069 | Snap N' Stain Iodine StainJTS · Traditional | 10/25/1988SE |
| K884011 | Snap N' Stain Iron StainGGH · Traditional | 10/06/1988SE |
| K883052 | Metheno-Stain KitJTS · Traditional | 08/30/1988SE |
| K881598 | SDL Trichrome StainJTS · Traditional | 05/04/1988SE |
| K840506 | Haemophilus Influenzae Type BLSC · Traditional | 04/04/1984SE |
Questions and answers
When was Parasafe(R) Fixative cleared by the FDA?
Parasafe(R) Fixative (K935316) received a 510(k) decision of Substantially Equivalent on February 17, 1994, 107 days after the submission was received.
What is the product code of K935316?
The FDA product code is LKS – Device, Parasite Concentration, a Class I (low risk) device regulated under 21 CFR 866.2900.